Flexible tamping device

ABSTRACT

A method and apparatus for sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being with an anchor, a sealing plug and a filament connecting the anchor and sealing plug. The method and apparatus provide for a tamping device that is coilable in some configurations and stiff and straight in other configurations. The coilable tamping device may also automatically tamp the sealing plug when the apparatus is withdrawn from the puncture site. The automatic uncoiling and tamping is facilitated by transducing a motive force generated by the withdrawal of the apparatus into a tamping force.

RELATED APPLICATION

This is a divisional of U.S. application Ser. No. 11/532,819 filed on 18Sep. 2006, the disclosure of which is incorporated, in its entirety, bythis reference.

FIELD OF THE INVENTION

This invention relates generally to medical devices and moreparticularly to devices for sealing punctures or incisions in aninternal tissue wall.

BACKGROUND

Various surgical procedures are routinely carried out intravascularly orintraluminally. For example, in the treatment of vascular disease, suchas arteriosclerosis, it is a common practice to invade the artery andinsert an instrument (e.g., a balloon or other type of catheter) tocarry out a procedure within the artery. Such procedures usually involvethe percutaneous puncture of the artery so that an insertion sheath canbe placed in the artery. The insertion sheath enables the introductionof other instruments (e.g., a catheter) to an operative position withinthe vascular system. Intravascular and intraluminal proceduresunavoidably present the problem of stopping the bleeding at thepercutaneous puncture after the procedure has been completed and afterthe instrument (and any insertion sheaths used therewith) has beenremoved. Bleeding from puncture sites, particularly in the case offemoral arterial punctures, is typically stopped by utilizing vascularclosure devices, such as those described in U.S. Pat. Nos. 6,179,863;6,090,130; and 6,045,569, which are hereby incorporated by thisreference.

Typical closure devices such as the ones described in theabove-mentioned patents place a sealing plug at the tissue puncturesite. Successful deployment of the sealing plug, however, requires thatit be manually ejected from within a device sheath and tamped down to anouter surface of the tissue puncture using a tamping tube. The tampingprocedure cannot commence until the device sheath (within which thetamping tube is located) has been removed so as to expose the tampingtube for manual grasping. Under certain conditions, removal of thesheath prior to tamping the sealing plug may cause the sealing plugitself to be retracted from the tissue puncture, hindering subsequentplacement of the sealing plug, and resulting in only a partial seal andassociated bleeding from the tissue puncture. Accordingly, there is aneed to improve the mechanism for deployment of the sealing plug at thesite of a tissue puncture.

SUMMARY

In one of many possible embodiments, the present invention provides atissue puncture closure device for partial insertion into and sealing ofan internal tissue wall puncture. The closure device includes a filamentextending from a first end of the closure device to a second end of theclosure device, an anchor for insertion through the tissue wall punctureattached to the filament at the second end of the closure device, asealing plug slidingly attached to the filament adjacent to the anchor,and an at least partially coiled tamping device adjacent to the sealingplug for advancing the sealing plug toward the anchor. The tissuepuncture closure device may include a spool at the first end, such thata portion of the tamping device coiled on the spool is flexible andfolded flat in cross-section, and a portion of the tamping deviceadjacent to the sealing plug is stiff and comprises a trough. A shaperdisposed at the first end may fold the portion of the tamping devicecoiled on the spool into the stiff trough configuration as it isadvanced distally therethrough. According to other embodiments, theshaper longitudinally folds the portion of the tamping device coiled onthe spool into a closed polygonal shape as it advances distallytherethrough.

According to some aspects of the invention the tamping device comprisesa first longitudinal section at least partially coiled on a first spooland a second longitudinal section at least partially coiled on a secondspool. The shaper then integrates the first longitudinal section of thetamping device coiled on the first spool and the second longitudinalsection of the tamping device coiled on the second spool into a stiff,generally straight member. Accordingly, each of the first and secondlongitudinal sections may comprise semi-circles in cross-section.

According to some aspects of the invention the tamping device includes achain that is flexible in a first coiling direction but rigid in adirection opposite of the first coiling direction. For example, thechain may be flexible if coiled in a clockwise direction, but rigidagainst coiling in a counter-clockwise direction. The chain may includea plurality of blocks, each block flexibly linked at one corner to aneighboring block.

According to some aspects of the invention there is an automaticuncoiling device for uncoiling the tamping device in response toretraction of the tissue puncture closure device from a tissue puncture.The automatic uncoiling device may include a spool with a portion of thefilament wound thereon, and a gear engaged with the spool.

Another embodiment of the invention provides a medical apparatusincluding a carrier tube, a handle attached to a first end of thecarrier tube, a filament extending between the first end of the carriertube and a second end of the carrier tube, an anchor attached to thefilament at the second end of the carrier tube, a sealing plug slidinglyattached to the filament proximal of the anchor, and a tamping devicedisposed about the filament for driving the sealing plug along thefilament distally towards the anchor. According to this embodiment, atleast a portion of the tamping device may be coiled within the handle.Moreover, the tamping device may extend through a shaper such that aportion of the tamping device proximal of the shaper comprises a curved,flexible configuration and a portion of the tamping device distal of theshaper comprises a straight, stiff configuration. The apparatus,including the filament and a filament storage spool may comprise adriving mechanism for advancing the tamping device toward the second endin response to a separation force between the anchor and the handle.

According to another embodiment there is a tissue puncture closuredevice for partial insertion into and sealing of an internal tissue wallpuncture accessible through a percutaneous incision, where the closuredevice comprises a filament connected at a distal end to an anchor andto a sealing plug located proximal of the anchor for disposition andanchoring about the tissue wall puncture, where the improvementcomprises means for automatically driving the sealing plug along thefilament in a distal direction towards the anchor simultaneously uponwithdrawal of the closure device from the tissue wall puncture and meansfor folding the means for automatically driving from a flexible coiledconfiguration to a straight, stiff configuration.

Another aspect of the invention provides a method of making an internaltissue puncture sealing device by providing a carrier tube, attaching ahandle at a first end of the carrier tube, extending a filament betweenthe first end of the carrier tube and a second end of the carrier tube,attaching an anchor to the filament at the second end of the carriertube, slidingly attaching a sealing plug to the filament proximal of theanchor, disposing a tamping device about the filament, and coiling atleast a portion of the tamping device in the handle. According to someembodiments the coiling comprises wrapping two components of the tampingdevice around two separate spools.

Another aspect provides a method of sealing a tissue puncture in aninternal tissue wall accessible through a percutaneous incision. Themethod may include withdrawing a closure device from the tissuepuncture, and automatically uncoiling a tamping device to tamp a sealingplug at the tissue puncture by transducing a motive force generated bywithdrawal of the closure device in a first direction to a tamping forcein a second direction. The automatic uncoiling further may includepassing the tamping device through a shaper and altering across-sectional shape of the tamping device, for example, to stiffen thetamping device. The transducing may include automatically unwinding afilament from a filament spool by deploying an anchor attached to thefilament inside the tissue puncture prior to withdrawing the closuredevice from the tissue puncture.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate various embodiments of the presentinvention and are a part of the specification. The illustratedembodiments are merely examples of the present invention and do notlimit the scope of the invention.

FIG. 1 is a side view, partly in section, of an internal tissue punctureclosure device according to the prior art.

FIG. 2 is a side view of the tissue puncture closure device of FIG. 1inserted through an insertion sheath and engaged with an artery, theartery shown in section, according to the prior art.

FIG. 3 is a side view of the tissue puncture closure device, insertionsheath, and artery of FIG. 2, wherein the tissue closure device andinsertion sheath are being withdrawn from the artery to deploy acollagen pad according to the prior art.

FIG. 4 is a side view of the tissue puncture closure device, insertionsheath, and artery shown in FIG. 3 with a tamping tube fully exposed andbeing used to tamp the collagen pad according to the prior art.

FIG. 5 is a side view of a tissue puncture closure device with anautomatic tamping device uncoiling mechanism shown with hidden linesaccording to one embodiment of the present invention; the tissue closuredevice is shown engaged with an artery.

FIG. 6A is an enlarged cross-sectional view taken along the line A-A ofthe tamping device shown in FIG. 5 according to one embodiment of thepresent invention.

FIG. 6B is an enlarged cross-sectional view taken along the line B-B ofthe tamping device shown in FIG. 5 according to one embodiment of thepresent invention.

FIG. 7A is an enlarged cross-sectional view of an alternative tampingdevice taken along the line A-A of the tamping device shown in FIG. 5according to one embodiment of the present invention.

FIG. 7B is an enlarged cross-sectional view of the alternative tampingdevice shown in FIG. 7A, taken along line B-B of the tamping deviceshown in FIG. 5 according to one embodiment of the present invention.

FIG. 8A is a top view of another alternative tamping device shown inFIG. 5 according to one embodiment of the present invention.

FIG. 8B is an enlarged cross-section view of the alternative tampingdevice shown in FIG. 8A taken along the line B-B of the tamping deviceshown in FIG. 5 according to one embodiment of the present invention.

FIG. 9A is an enlarged side-view of a coiled portion of a tamping devicefor use with the tissue puncture closure device of FIG. 5 according toanother embodiment of the present invention.

FIG. 9B is an enlarged side-view of an uncoiled portion of the tampingdevice shown in FIG. 9A according to one embodiment of the presentinvention.

FIG. 10A is a side-view, partly in section, of a tissue puncture closuredevice with a multi-part tamping device according to another embodimentof the present invention.

FIG. 10B is an enlarged cross-sectional view taken along the line10B-10B of the tamping device shown in FIG. 10A according to oneembodiment of the present invention.

FIG. 11 is a side view of the tissue puncture closure device of FIG. 5being withdrawn from the artery according to one embodiment of thepresent invention.

FIG. 12 is an partial assembly view of the tissue puncture closuredevice of FIG. 5 according to one embodiment of the present invention.

FIG. 13 is an enlarged cross-sectional side view a tissue punctureclosure device with an electrical transducer according to one embodimentof the present invention.

Throughout the drawings, identical reference numbers designate similar,but not necessarily identical, elements.

DETAILED DESCRIPTION

As mentioned above, vascular procedures are conducted throughout theworld and require access to an artery through a puncture. Most often,the artery is a femoral artery. To close the puncture followingcompletion of the procedure, many times a closure device is used tosandwich the puncture between an anchor and a sealing plug. However,sometimes the sealing plug is not properly seated against an exteriorsitus of the arteriotomy. If the plug does not seat against thearteriotomy, there is a potential for elongated bleeding. The presentinvention describes methods and apparatus to reduce or eliminatemovement or misplacement of the sealing plug with a compact device.While the vascular instruments shown and described below includeinsertion sheaths and puncture sealing devices, the application ofprinciples described herein are not limited to the specific devicesshown. The principles described herein may be used with any vascularclosure device. Therefore, while the description below is directedprimarily to arterial procedures and certain embodiments of a vascularclosure device, the methods and apparatus are only limited by theappended claims.

As used throughout the claims and specification the term “tamp” or“tamping” is used broadly to mean pushing or packing by one or asuccession of pushes, blows, or taps, but not by excessive force. Theterm “effecting” means producing an outcome, achieving a result, orbringing about. “Coiled” means rings formed by winding, and includespartial windings and arcs. An “arc” is something shaped like a curve orarch, including a segment of a circle or ellipse. A “spool” is acylinder or other device on which something else is at least partiallywound. A “lumen” refers to any open space or cavity in a bodily organ,especially in a blood vessel. A “shaper” is any device that changes thecross-sectional shape, bending moment, or linearity of another device.The words “including” and “having,” as used in the specification,including the claims, have the same meaning as the word “comprising.”

Referring now to the drawings, and in particular to FIGS. 1-4, avascular puncture closure device 100 is shown according to the priorart. The vascular puncture closure device 100 includes a carrier tube102 with a filament or suture 104 extending at least partiallytherethrough. The closure device also includes a first or proximal end106 and a second or distal end 107. External to a second or distal end107 of the carrier tube 102 is an anchor 108. The anchor is anelongated, stiff, low profile member including an eye 109 formed at themiddle. The anchor 108 is typically made of a biologically resorbablepolymer.

The suture 104 is threaded through the anchor 108 and back to a collagenpad 110. The collagen pad 110 may be comprised of randomly orientedfibrous material bound together by chemical means. The collagen pad 110is slidingly attached to the suture 104 as the suture passes distallythrough the carrier tube 102, but as the suture traverses the anchor 108and reenters the carrier tube 102, it is securely slip knotted proximalto the collagen pad 110 to facilitate cinching of the collagen pad 110when the closure device 100 is properly placed and the anchor 108deployed (see FIG. 4).

The carrier tube 102 typically includes a tamping tube 112 disposedtherein. The tamping tube 112 is slidingly mounted on the suture 104 andmay be used by an operator to tamp the collagen pad 110 toward theanchor 108 at an appropriate time to seal a percutaneous tissuepuncture. Prior to deployment of the anchor 108 within an artery, theeye 109 of the anchor 108 rests outside the distal end 107 of thecarrier tube 102. The anchor 108 may be temporarily held in place flushwith the carrier tube 102 by a bypass tube 114 disposed over the distalend 107 of the carrier tube 102.

The flush arrangement of the anchor 108 and carrier tube 102 allows theanchor 108 to be inserted into an insertion sheath 116 as shown in FIGS.2-4, and eventually through an arterial puncture 118. The insertionsheath 116 is shown in FIGS. 2-4 inserted through a percutaneousincision 119 and into an artery 128. However, the bypass tube 114(FIG. 1) includes an oversized head 120 that prevents the bypass tube114 from passing through an internal passage of the insertion sheath116. Therefore, as the puncture closure device 100 is inserted into theinsertion sheath 116, the oversized head 120 bears against a surface 122of insertion sheath 116. Further insertion of the puncture closuredevice 100 results in sliding movement between the carrier tube 102(FIG. 1) and the bypass tube 114, releasing the anchor 108 from thebypass tube 114 (FIG. 1). However, the anchor 108 remains in the flusharrangement shown in FIG. 1 following release from the bypass tube 114,limited in movement by the insertion sheath 116.

The insertion sheath 116 includes a monofold 124 at a second or distalend 126 thereof. The monofold 124 acts as a one-way valve to the anchor108. The monofold 124 is a plastic deformation in a portion of theinsertion sheath 116 that elastically flexes as the anchor 108 is pushedout through the distal end 126 of the insertion sheath 116. Typically,after the anchor 108 passes through the distal end 126 of the insertionsheath 116 and enters the artery 128, the anchor 108 is no longerconstrained to the flush arrangement with respect to the carrier tube102 and it deploys and rotates to the position shown in FIG. 2.

Referring next to FIGS. 3-4, with the anchor 108 deployed, the punctureclosure device 100 and the insertion sheath 116 are withdrawn together,depositing the collagen pad 110 in the incision tract 119 and exposingthe tamping tube 112. With the tamping tube 112 fully exposed as shownin FIG. 4, the collagen pad 110 is manually tamped, and the anchor 108and collagen pad 110 are cinched together and held in place with aself-tightening slip-knot on the suture 102. Thus, the tissue punctureis sandwiched between the anchor 108 and the collagen pad 110, therebysealing the tissue puncture 118. The suture 104 is then cut and thepuncture 118 may be closed. The suture 104, anchor 108, and collagen pad110 are generally made of resorbable materials and therefore remain inplace while the puncture 118 heals.

Using the typical tissue puncture closure device 100 described above,however, the tamping of the collagen pad 110 cannot commence until thesheath 116 has been removed so as to expose the tamping tube 112 formanual grasping. Under certain conditions, removal of the sheath 116prior to tamping the collagen pad 110 causes the collagen pad 110 toretract from the tissue puncture 118, creating a gap 120 between thecollagen pad 110 and the puncture 118. The gap 120 may remain even aftertamping as shown in FIG. 4, and sometimes results in only a partial sealand bleeding from the tissue puncture 118.

Therefore, the present specification describes a tissue puncture closuredevice with a tamping tube that is at least partially coiled, which mayautomatically drive a sealing plug (such as collagen pad 110) toward atissue puncture upon withdrawal of the tissue puncture closure devicefrom the tissue puncture site. While the preferred embodiments of thetissue puncture closure device are shown and described below, theprinciples of the present specification may be incorporated into any ofa number of tissue closure devices. The specific embodiments describedbelow are for illustrative purposes only, and are not limiting.

As described above, the general structure and function of tissue closuredevices used for sealing a tissue puncture in an internal tissue wallaccessible through an incision in the skin are well known in the art.Applications of closure devices including those implementing principlesdescribed herein include closure of a percutaneous puncture or incisionin tissue separating two internal portions of a living body, such aspunctures or incisions in blood vessels, ducts or lumens, gall bladders,livers, hearts, etc.

Referring now to FIG. 5, a medical apparatus, for example a tissuepuncture closure device 200 is shown according to one embodiment of thepresent invention. The closure device 200 has particular utility whenused in connection with intravascular procedures, such as angiographicdye injection, cardiac catheterization, balloon angioplasty and othertypes of recanalizing of atherosclerotic arteries, etc. as the closuredevice 200 is designed to cause immediate hemostasis of the blood vessel(e.g., arterial) puncture. However, it will be understood that while thedescription of the preferred embodiments below are directed to thesealing off of percutaneous punctures in arteries, such devices havemuch more wide-spread applications and can be used for sealing puncturesor incisions in other types of tissue walls as well. Thus, the sealingof a percutaneous puncture in an artery, shown herein, is merelyillustrative of one particular use of the tissue closure device 200 ofthe present invention.

The tissue closure device 200 includes a first or proximal end 206 and asecond or distal end 207. A carrier tube 202 extends from the proximalend 206 to the distal end 207 and includes an outlet 213 at the distalend 207. The carrier tube 202 may be made of plastic or other materialand is designed for insertion through a sheath 216, which is designedfor insertion through a percutaneous incision 219 in a tissue layer 230and into a lumen 232. According to FIG. 5, the lumen 232 comprises aninterior portion of a femoral artery 228.

At the distal end 207 of the carrier tube 202 there is an anchor 208 anda sealing plug 210. The anchor 208 of the present embodiment is anelongated, stiff, low-profile member arranged to be seated inside theartery 228 against an artery wall 234 contiguous with a puncture 218.The anchor 208 is preferably made of a biologically resorbable polymer.The sealing plug 210 is formed of a compressible sponge, foam, orfibrous mat made of a non-hemostatic biologically resorbable materialsuch as collagen, and may be configured in any shape so as to facilitatesealing the tissue puncture 218.

The sealing plug 210 and anchor 208 are connected to one another by afilament or suture 204 that is also biologically resorbable. The anchor208, the sealing plug 210, and the suture 204 are collectively referredto as the “closure elements” below. As shown in FIG. 5, the anchor 208is arranged adjacent to and exterior of the distal end 207 of thecarrier tube 202, while the sealing plug 210 is initially disposedwithin carrier tube 202. Although the anchor 208 is shown deployed witha first surface 236 abutting the artery wall 234, it will be understoodthat initially the anchor is arranged axially along the carrier tube 202to facilitate insertion into the lumen 232 (see, for example, the anchor108 of FIG. 1). The suture 204 extends distally from the proximal end206 of the closure device 200 through the carrier tube 202. The suture204 is threaded through one or more perforations in the sealing plug210, through a hole in the anchor 208, and proximally back toward thecarrier tube 202 to the sealing plug 210. The suture 204 is preferablythreaded again through a perforation or series of perforations in thesealing plug 210. The suture 204 may also be threaded around itself toform a self-tightening slip-knot. The suture 204 thus connects theanchor 208 and the sealing plug 210 in a pulley-like arrangement tocinch the anchor 208 and the sealing plug 210 together when the carriertube 202 is pulled away from the anchor 208 and the sealing plug 210,sandwiching and locking the anchor and plug together and thereby sealingthe tissue puncture 218.

The carrier tube 202 also houses a tamping device, for example the atleast partially coiled tamping device 212 shown in FIG. 5, for advancingthe sealing plug 210 along the suture 204 and toward the anchor 208. Thetamping device 212 is shown with a first portion 242 partially coiledwithin a handle 252 and a second portion 244 extending distally towardthe sealing plug 210. The first portion 242 may be coiled around a spoolor arranged in between guides 240, 241 (FIG. 12). The first portion 242includes a variable length of the tamping device 212 proximal of ashaper 246 and the second portion 244 includes a variable length of thetamping device 212 distal of the shaper 246. The shaper 246 is shown inmore detail below with reference to FIG. 12 and may alter across-section and/or increase a moment of inertia along certain axes ofsome embodiments of the tamping device 212 as it passes therethrough.Accordingly, the first portion 242 of the tamping device 212 isgenerally flexible and therefore coilable in at least one direction, butthe second portion 244 is generally stiff and straight.

The tamping device 212 may comprise any number of configurations thatenable the first portion 242 to coil and the second portion 244 tostraighten and stiffen. The first portion 242 facilitates compaction ofthe closure device 200 by storing a length of the tamping device 212 ina non-linear coil. The second portion 244 facilitates advancing ortamping the sealing plug 210 toward the anchor 208. Several examples ofdifferent configurations of the tamping device 212 are shown anddescribed below with reference to FIGS. 6A-10B.

Referring to FIGS. 6A-6B, one embodiment of the tamping device 212 isshown according to principles of the present invention. According toFIG. 6A, which is a cross sectional view of the tamping device 212 takenalong line A-A of FIG. 5, the first portion 242 of the tamping devicecomprises a generally open, flat cross-section. The generally flat crosssection of the first portion 242 of the tamping device 212 has agenerally low moment of inertia about an X-axis and therefore providesfor flexibility about the X-axis of the tamping device 212. The tampingdevice 212 as shown in FIG. 6A may include a pair of notches 251 whichweaken the structure and that facilitate folding or bending the tampingdevice into a different cross-sectional configuration.

According to the embodiment of FIGS. 6A-6B, as the first portion 242 ofthe tamping device 212 passes through the stationary shaper 246 (FIG.5), it is folded to form a different cross-sectional as shape shown inFIG. 6B. FIG. 6B represents a cross sectional view of the tamping device212 taken along line B-B of FIG. 5. Accordingly, FIG. 6B represents thecross section of the second portion 244 of the tamping device 212. Asshown in FIG. 6B, the tamping device 212 is folded to form a trough, ora general U or V-shape. Accordingly, the shaper 246 (FIG. 5) maycomprise wedge surfaces forming a trough. The trough-shape formed in thesecond portion 244 of the tamping device 212 has a much higher moment ofinertia about the X-axis and is therefore much more stiff, rigid, andstraight as compared to the flat configuration of the first portion 242(FIG. 6A). Therefore, the second portion 244 of the tamping device iswell suited for bearing against and tamping the sealing plug 210 (FIG.5) toward the anchor 208 (FIG. 5). The folding of the tamping devicebetween flexible and stiff configurations as shown in FIGS. 6A-6Bfacilitates a compact closure device 200 by allowing a sufficient lengthof the tamping device 212 to be coiled within the handle 252 of theclosure device 200, and also provides adequate stiffness to the tampingdevice 212 at the sealing plug 210 (FIG. 5).

Another embodiment of the tamping device 212 is shown in cross-sectionin FIGS. 7A-7B. Similar to the configuration shown in FIG. 6A, theembodiment of FIG. 7A illustrates a cross section taken along line A-Aof FIG. 5 of the first portion 242 of the tamping device 212. The firstportion 242 is arranged in a generally open, flexible, flatconfiguration that allows the first portion 242 to be convenientlycoiled. The tamping device 212 of FIGS. 7A-7B, however, includes a twoor more notches 254 that facilitate folding the tamping device 212 intoa closed polygonal shape. In addition, a first edge 256 of the tampingdevice 212 may include a protrusion 258 and a second edge 260 mayinclude a mating cavity 262 that provides a snap-lock geometry for thetamping device 212 when folded. For example, as shown in FIG. 7B, whichis a cross section of the second portion 244 of the tamping device 212taken along line B-B of FIG. 5, the second portion 244 of the tampingdevice 212 may be folded by the shaper 246 (FIG. 5) into a triangularshape. As with the trough-shape of FIG. 6B, the triangular shape of FIG.7B has a much higher moment of inertia about the X-axis and is thereforemuch stiffer in directions transverse to its longitudinal axis 250 thanthe flat configuration of FIG. 7A. Those of skill in the art having thebenefit of this disclosure will understand that other closed polygonalshapes may also be formed from a generally flat configuration by theshaper 246 (FIG. 5) and that the triangular shape is merely exemplary.The shaper 246 (FIG. 5) may include various wedges or surfaces to foldthe tamping device 212 into any desirable configuration as it passestherethrough.

Other embodiments may be used as well. For example, the embodiment ofFIGS. 8A-8B illustrates another configuration for the tamping device 212that may be folded between flexible and stiff arrangements. FIG. 8Aillustrates a top view of the first portion 242 of FIG. 5 and isgenerally flat therefore coilable, with toothed edges that engage whenfolded to stiffen the tamping device 212 and prevent edge sliding.Following folding by the shaper 246 (FIG. 5), the toothed edges engageto form a closed polygon in cross-section, such as the triangle shown inFIG. 8B, which illustrates the second portion 244 of the tamping device212 taken along line B-B of FIG. 5.

However, instead of using the shaper 246 to alter the cross section ofthe tamping device 212 shown in FIG. 5, some embodiments of the tampingdevice 212 may be coilable in one direction and stiff in otherdirections without any folding or changing of the cross section.Accordingly, some embodiments of the closure device 200 may not includethe shaper 246. For example, the tamping device may comprise a chain 312as shown in FIGS. 9A-9B. FIGS. 9A-9B illustrate the chain 312 from aside view rather than a cross-sectional view. The chain 312 is flexiblein a first direction represented by an arced arrow 360 in FIG. 9A, butrigid in other directions including a second direction represented by asecond arced arrow 362 shown in FIG. 9B.

The chain 312 as shown in FIGS. 9A-9B includes a plurality of blocks 364flexibly linked together. Each of the blocks 364 is connected to aneighboring block at one corner by a flexible member 366. The flexiblemember 366 may comprise a plastic sheet or some other material that iseasily bent. As shown in FIGS. 9A-9B, the chain 312 may be coiled in thefirst direction 360 within the handle 252 (FIG. 5), but the blocks 364bear against and interfere with one another to prevent coiling in otherdirections. Further, the chain 312 may be biased by the flexible member366 in the second direction 362 so that as the chain 312 is uncoiled, ittends to form the straight, rigid shape illustrated in FIG. 9B. Thestraight, rigid shape of FIG. 9B provides an effective tamping devicefor advancing the sealing plug 210 (FIG. 5) toward the anchor 208 (FIG.5) along the suture 204 (FIG. 5).

Moreover, according to other embodiments, a tamping device 412 (FIG.10A-10B) may comprise multiple components. As shown in FIGS. 10A-10B,the tamping device 412 includes a first longitudinal section 468 atleast partially coiled, and a second longitudinal section 472 at leastpartially coiled. The first longitudinal section 468 may be partiallycoiled onto a first spool 470, and the second longitudinal section 472may be partially coiled onto a second spool 474. However, the first andsecond longitudinal sections 468, 472 may also be guided by first andsecond external surfaces 476, 478 into the coiled configuration shown.According to FIGS. 10A-10B, the first and second longitudinal sections468, 472 are mating halves of the tamping device 412 that integrate ormesh together to form a generally circular cross-section as shown inFIG. 10B. Once meshed, the first and second longitudinal sections 468,472 comprise a generally straight, stiff tube that functions well as atamping device. The second longitudinal section 472 is advanced orretracted by a main drive gear 480, and the first longitudinal section468 is simultaneously advanced or retracted by a slave drive gear 482preferably engaged with the main drive gear 480. The main drive gear 480is preferably driven by the suture 204 (FIG. 5) as described below withreference to FIGS. 11-12.

Turning now to FIG. 11, the suture 204 extends through the secondsection 244 of the tamping device 212 but is not directly connectedthereto. Therefore, the suture 204 and tamping device 212 are free toslide past one another. According to the embodiment shown in FIGS.11-12, as the suture 204 extends into the handle 252 it attaches to anautomatic uncoiling mechanism 530 housed within the handle 252.

In practice, the carrier tube 202 of the closure device 200 (containingthe closure elements described above) is inserted into the insertionsheath 216, which is already inserted through the artery wall 228. Asthe closure device 200 and the associated closure elements are insertedinto the insertion sheath 216, the anchor 208 passes through and out ofthe distal end 207 of the insertion sheath 216 and is inserted into thearterial lumen 232. As mentioned above, the anchor 208 is initiallyarranged substantially parallel with the carrier tube 202 to facilitateinsertion of the anchor 208 through the percutaneous incision 219 andinto the lumen 232. As the anchor 208 passes out of the insertion sheath216 and into the lumen 232, the anchor 208 rotates to the position shownin FIG. 11.

With anchor 208 rotated transversely within the lumen 232 as shown inFIG. 11, the closure device 200 and the insertion sheath 216 arewithdrawn together, causing the surface 236 of the anchor 208 to bearagainst the artery wall 234. Further retraction of the closure device200 and insertion sheath 216 causes the sealing plug 210 to withdrawfrom the distal end 207 of the carrier tube 202, thereby depositing theplug within the incision or puncture tract 219.

However, unlike previous closure devices that require a separate, manualtamping procedure following the deposition of the sealing plug 210, theclosure device 200 of the present invention may automatically tamp thesealing plug 210 with the partially coiled tamping device 212. Theclosure device 200 uncoils and drives the tamping device 212 toward thesealing plug 212 automatically upon withdrawal of the closure device 200from the puncture tract 219, tamping the sealing plug 210 toward theanchor 208 as shown in FIG. 11. Therefore, the sealing plug 210 istamped while the carrier tube 216 is still arranged adjacent to thepuncture 218 in the femoral artery 228, reducing or eliminating any gapsthat may otherwise occur between the sealing plug 210 and the puncture218 in the artery wall 228.

In addition, by placing tension on or pulling the suture 204 away fromthe puncture tract 219, the suture 204 cinches and locks (with a slipknot or the like) the anchor 208 and the sealing plug 210 together,sandwiching the artery wall 228 between the anchor 208 and sealing plug210. The force exerted by the tamping device 212 and the cinchingtogether of the anchor 208 and sealing plug 210 by the filament 204 alsocauses the sealing plug 210 to deform radially outward within thepuncture tract 219 and function as an anchor on the proximal side of thetissue puncture 218.

Automatically uncoiling (and, depending on the coiled shape of thetamping device 212, shaping) the tamping device 212 toward the sealingplug 210 and/or cinching the seal plug 210 and the anchor 208 may befacilitated by any of a number of mechanisms. For example, the automaticuncoiling mechanism 530 that may be disposed in the handle 252 of theclosure device 200 is shown in FIG. 12. According to the embodiment ofFIG. 12, retraction of the closure device 200 automatically effectstamping of the sealing plug 210 (FIG. 11). A portion of the forcerequired to retract the closure device 200 from the puncture 218 (FIG.11) is automatically transduced to an opposite driving force by theautomatic uncoiling mechanism 530.

According to the automatic uncoiling mechanism 530 of FIG. 12 (andsimilarly for FIG. 10A), the suture 204 is connected to and wound abouta suture spool 532 (or main drive gear 480 of FIG. 10A). Withdrawal ofthe closure device 200 (FIG. 11) from the tissue puncture site (if theanchor 208 (FIG. 11) is deployed) causes the suture 204 to unwind fromthe suture spool 532. The suture spool 532 rotates as the suture 204unwinds and provides a torsional motive force that may be transduced toa driving or uncoiling force to the tamping device 212.

According to the embodiment of FIG. 12, the torsional motive forceprovided by the spool 532 is transduced into the driving force for thetamping device 212 by a gear train 534. The gear train 534 includes afirst gear 536 arranged coaxially with the suture spool 532. The firstgear 536 and the spool 532 may include mating fan surfaces 538, 540,respectively. The mating fan surfaces 538, 540 define a torque-limitingclutch that prevents the transmission of exceptional torsional forcesfrom the spool 532 to the first gear 536 that exceed a predeterminedlevel.

The matching fan surfaces 538, 540 of the first gear 536 and suturespool 532 may be forced into engagement by a biasing member, such as acompressible washer 550, with sufficient force to cause mechanical orfrictional engagement of the fan gears surfaces 538, 540, while stillpermitting mutual rotation about an axis of rotation 552. The fansurfaces 538, 540 are preferably sinusoidally shaped so as to permitslippage between the fan surfaces 538, 540 only when torsional forcesreach or exceed a predetermined level. It will be understood, however,that other fan surface shapes may also be used, including, but notlimited to, V-shapes, square shapes and flat surfaces. The predeterminedtorsional force level necessary to overcome the mechanical or frictionalengagement of the fan surfaces 538, 540 may be modified by adjusting thefrequency or amplitude of the sinusoidally shaped fan faces, byadjusting the biasing force between the fan surfaces 538, 540, or byother methods.

As shown in FIG. 12, the first gear 536 may engage a second gear 542.The first and second gears 536, 542 may engage one another with africtional fit or with gear teeth. The second gear 542 also engages anduncoils the tamping device 212, which is disposed between the secondgear 542 and a roller guide 546. When the spool 532 rotates, the secondgear 542 drives the first section 242 of tamping device 212, which isinitially coiled, through the shaper 246. The shaper 246, may, however,be arranged downstream of the second gear 542 as well. The shaper 246may fold certain embodiments of the tamping device 212/312/412 into newstiffer configurations, straighten the tamping device 212/312/412,and/or help mesh multiple tamping device components into a single piece.The second gear 542 also drives the tamping device 212 toward thesealing plug 210 (FIG. 11) and thus advances the sealing plug 210 (FIG.11) toward the anchor 208 (FIG. 11). It will be understood by theskilled artisan having the benefit of this disclosure that although theshaper 246 (FIG. 5) is shown in FIG. 5 distal of the gears such assecond gear 542, the shaper 246 may also be located proximal of thegears.

It may be desirable in some cases to increase the linear velocity of thetamping device 212 relative to the linear velocity at which the closuredevice 200 may be withdrawn. An increased linear velocity for thetamping device 212 may better assure that the sealing plug 210 (FIG. 11)is forced toward the anchor 208 (FIG. 11) when the closure device 200 iswithdrawn from the puncture 218 (FIG. 11). Therefore, according to someembodiments, the gear train 534 may have an overall gear ratio greaterthan 1:1, and may include additional gears. For example, the gear ratiomay range between approximately 2.5:1 and 6.0:1 for some embodiments.According to some embodiments the gear ratio is about 5.0:1.

However, it should be noted that the linear velocity of the tampingdevice should not be excessively greater than the linear withdrawalvelocity of the closure device, as excessive speed could potentiallyforce the sealing plug 210 (FIG. 11) through the tissue puncture 218(FIG. 11) and into the lumen 232 (FIG. 11). Likewise, an insufficientopposing force against the anchor 208 (FIG. 11) could potentially resultin the anchor 208 (FIG. 11) being pulled out of place from within thelumen 232 (FIG. 11). Therefore, according to some uses, the withdrawalforce should not exceed approximately 3.5 pounds.

It will be understood by those of skill in the art having the benefit ofthis disclosure that the drive spool/gear train configuration shown inFIGS. 10A and 12 are exemplary in nature, and not limiting. Any gearconfiguration may be used to transmit a motive force generated byretraction of the closure device 200 (FIG. 11) to provide an automaticdriving force to the sealing plug 210 (FIG. 11). In addition, thetorque-limiting clutch may be arranged at any point along the gear train534 and is not limited to the engagement between the suture spool 532and the first gear 536.

Operation of the closure device 200 of FIGS. 11-12 is as follows. As theclosure device 200 is retracted from the puncture tract 219, aseparation force between the handle 252 and the anchor 208 causes thesuture 204, which is threaded through the anchor 208, to unwind from androtate the spool 532. The spool 532 drives the first gear 536 as itrotates via the mating engagement between the fan surfaces 538, 540. Asthe first gear 536 rotates it drives the second gear 542, and the secondgear 542 drives the tamping device 212. The tamping device 212 passesthrough the shaper 246 where it is arranged into a stiff, straightconfiguration. The tamping device 212 extends toward and tamps thesealing plug 210. Therefore, as the closing device 200 is retracted fromthe puncture tract 219, the sealing plug 210 is automatically tamped viathe automatic driving mechanism 530. Accordingly, the sealing plug 210is more likely to create a sufficient arterial seal without gaps betweenthe sealing plug 210 and the anchor 208, as may otherwise occur with aseparate manual tamping procedure.

Although the embodiments shown and described above illustrate mechanicaltransducers that may be used to convert forces associated withretraction of the closure tool 200 to an automatic tamping force on thesealing plug 210, other transducers may also be used according toprinciples of the invention to facilitate automatic tamping of thesealing plug 210. Any means for transducing a motive force in a firstdirection to a subsequent force in another direction may be used. Forexample, referring to FIG. 13, electrical switches and/or opticaltransducers may be used to generate an automatic tamping force uponretraction of the closure tool 200 from a puncture tract. Accordingly,an electrical switch and/or optical sensor 660 may transmit a signalalong a communications interface 662 to a motor, servo, solenoid, orother device 664 indicating retraction of the closure device 200. Themotor, servo, solenoid, or other device 264 may then provide a tampingforce when the retraction signal is received.

Therefore, according to some embodiments the proximal end of the suture204 may be operatively connected to the electronic switch 660, which isoperatively connected to the motor 664 (and/or a power source).Retraction of the closure device 200 may trip the electronic switch 660and activate the motor 664 to generate a force used to uncoil thetamping device 212 and tamp the sealing plug 210. Similarly, theelectronic switch 660 may be or include an optical sensor for detectingand/or measuring withdrawal of the closure device 200 from the tissuepuncture and generating a signal indicating withdrawal of the closuredevice from the tissue puncture. The optical signal may be transduced toan electrical signal, and the electrical signal may be transmitted tothe motor 664 (and/or a power source) for generating a driving ortamping force to the sealing plug 210. The motor, servo, solenoid, orother device 664 may be rotary for generating torsional force (which maybe transduced to a linear motive force in a manner similar to thatdescribed above), or it may be linear for generating a force that may bedirectly or indirectly applied to the tamping device 212.

The tissue closure devices 200 described above may be particularlyuseful following an intravascular procedure, such as angioplasty orcatheterization. Therefore, the general steps that may be taken for sucha procedure are described below, followed by a number of steps that maybe taken according to some methods prior to use of the tissue closuredevice 200.

According to a standard intravascular procedure, a cannula of aninstrument, such as an angiographic needle, is inserted through the skininto an artery (e.g. a femoral artery) at the situs for the instrument'sinsertion. The angiographic needle is held in place and a flexibleguidewire is passed through the needle longitudinally into the arteryuntil it reaches a desired depth. Once the guidewire is in place, theangiographic needle is removed, leaving the guidewire in place. Aprocedure sheath and an arterial dilator are passed over the guidewire,through the puncture or incision, and into the artery. The guidewire andthen the dilator are removed, leaving the procedure sheath in place. Acatheter or other intravascular instrument is then inserted through theprocedure sheath and through the artery to the desired intravascularlocation, e.g., the situs of an atherosclerotic occlusion. Uponcompletion of the intravascular procedure (e.g., angioplasty), thecatheter is removed, leaving the procedure sheath in place.

The procedure sheath may then be used to facilitate introduction of theclosure device 200. First, another guidewire is used to assist inlocating the artery. The procedure sheath may then be removed, leavingthe guidewire in place. The insertion sheath 216 and a dilator are theninserted along the guidewire, through the percutaneous incision andtissue puncture, and into the artery. The guidewire and dilator areremoved, and the insertion sheath 216 is left in place and used foraccessing the tissue puncture with the tissue closure device 200 asdescribed above.

The preceding description has been presented only to illustrate anddescribe exemplary embodiments of invention. It is not intended to beexhaustive or to limit the invention to any precise form disclosed. Manymodifications and variations are possible in light of the aboveteaching. It is intended that the scope of the invention be defined bythe following claims.

1. A method of sealing a tissue puncture in an internal tissue wallaccessible through a percutaneous incision, comprising: withdrawing aclosure device from the tissue puncture; automatically uncoiling apartially coiled tamping device to tamp a sealing plug toward the tissuepuncture by transducing a motive force generated by withdrawal of theclosure device in a first direction to a tamping force in a seconddirection; wherein the tamping device includes a differentcross-sectional shape when coiled than when uncoiled.
 2. A method ofsealing a tissue puncture in an internal tissue wall accessible througha percutaneous incision according to claim 1, wherein the automaticallyuncoiling further comprises: passing the tamping device through a shaperto alter the cross-sectional shape of the tamping device.
 3. A method ofsealing a tissue puncture in an internal tissue wall accessible througha percutaneous incision according to claim 1, wherein the automaticallyuncoiling further comprises: passing the tamping device through a shaperto alter the cross-sectional shape of the tamping device; wherein thealtering stiffens the tamping device.
 4. A method of sealing a tissuepuncture in an internal tissue wall accessible through a percutaneousincision according to claim 1, wherein the transducing further comprisesautomatically unwinding a filament from a filament spool by deploying ananchor attached to the filament inside the tissue puncture prior towithdrawing the closure device from the tissue puncture.
 5. A method ofsealing a tissue puncture in an internal tissue wall accessible througha percutaneous incision according to claim 1, wherein the tamping devicewhen uncoiled has a trough cross-sectional shape.
 6. A method of sealinga tissue puncture in an internal tissue wall accessible through apercutaneous incision according to claim 1, wherein the tamping devicewhen uncoiled has a cross-sectional shape with a plurality of bends. 7.A method of sealing a tissue puncture in an internal tissue wallaccessible through a percutaneous incision, comprising: providing atissue puncture closure device comprising a filament connected at itsdistal end to an anchor and to a sealing plug located proximal of theanchor for disposition and anchoring about the tissue puncture;inserting the tissue puncture closure into the percutaneous incision;deploying the anchor into the tissue puncture; withdrawing the closuredevice from the percutaneous incision; automatically uncoiling a tampingdevice upon withdrawal of the closure device from the internal tissuewall puncture; reshaping a cross-section of the tamping device; tampingthe sealing plug toward the anchor.
 8. A method according to claim 7,wherein the reshaping includes contacting the tamping device with ashaper.
 9. A method according to claim 7, wherein the reshaping includeschanging the cross-section of the tamping device from a flatcross-section to a folded cross-section.
 10. A method according to claim8, wherein the folded cross-section includes a trough shape.
 11. Amethod according to claim 7, wherein the tamping device includes atleast one recess along its length, and the reshaping includes bendingthe tamping device at the recess.
 12. A method of treating a vascularincision, comprising: providing a vascular closure device having afilament, an anchor, a sealing plug, and an at least partially coiledtamping device, the filament extending from a first end to a second endof the closure device, the anchor attached to the filament at the secondend of the device, the sealing plug slidingly attached to the filamentadjacent to the anchor, and the tamping device having a distal endarranged adjacent to the sealing plug; inserting the anchor through thevascular incision at a location distal of the vascular incision;withdrawing the vascular closure device to dispose the sealing plugproximal of the vascular incision; uncoiling the tamping device tocompact the sealing plug toward the anchor, wherein uncoiling thetamping device includes changing a cross-sectional shape of the tampingdevice.
 13. A method according to claim 12, wherein changing across-sectional shape of the tamping device includes changing from aflat cross-section to a trough shaped cross-section.
 14. A methodaccording to claim 12, wherein changing a cross-sectional shape of thetamping device includes folding the tamping device.
 15. A methodaccording to claim 12, wherein the vascular closure device furtherincludes a shaper positioned at the first end, wherein uncoiling thetamping device includes contacting the tamping device with the shaper tochange the cross-sectional shape of the tamping device.
 16. A methodaccording to claim 15, wherein the shaper is positioned distal of acoiled portion of the tamping member.
 17. A method according to claim12, wherein changing a cross-sectional shape of the tamping deviceincludes changing from a flat cross-sectional shape to a one of: aU-shaped, a V-shaped, or a closed polygonal shaped cross-section.
 18. Amethod according to claim 12, wherein the filament is coiled around aspool, wherein rotating the spool by unwinding the filament rotates atleast one gear to unwind the tamping device.
 19. A method according toclaim 12, wherein the vascular closure device further comprises anautomatic unwinding device for unwinding the tamping device in responseto retraction of the tissue puncture closure device from the tissuepuncture.
 20. A method according to claim 15, wherein a portion of thetamping device proximal of the shaper comprises a curved, flexibleconfiguration and a portion of the tamping device distal of the shapercomprises a straight, stiff configuration.